HTL STREFA S A

HTL Strefa S.A. specializes in devices for blood collection and injection, including single-use and reusable options. Their portfolio covers blood lancets (both single-use and reusable manual devices), autoinjector needles, insulin syringes (basic and safety variants), hypodermic needles, general-purpose syringes, and needle guards. Examples include the Clickfine series for insulin administration, Acti-Lance and Medlance Plus safety lancets, and DropSafe variants designed to minimize needle-stick risks.

HTL Strefa S.A. is based in Poland, which means their devices are subject to both European and U.S. regulatory frameworks. Under EU Medical Device Regulations, their products fall into Class I or Class II/IIa classifications, requiring compliance with EUDAMED listings. Additionally, their devices are registered in the FDA’s 510(k) and UDI systems, demonstrating adherence to U.S. medical device regulations.

HTL Strefa S.A.’s devices are listed in multiple regulatory databases to ensure transparency and compliance. Their products appear in the EUDAMED database under EU Medical Device Regulations, as well as in the FDA’s 510(k) pre-market notification system and UDI (Unique Device Identification) registry. These listings reflect their global distribution and adherence to both European and U.S. regulatory standards.

HTL Strefa S.A.’s devices are classified under EU Medical Device Regulations primarily as Class I (low-risk) or Class II/IIa (moderate-risk), depending on their intended use and potential risk to patients. For example, single-use blood lancets and general-purpose syringes typically fall under Class I, while safety lancets or insulin syringes with additional features may qualify as Class II/IIa. This classification determines the regulatory requirements they must meet, such as conformity assessments and post-market surveillance.

HTL Strefa S.A. offers insulin syringes and lancets with specific safety and usability features. Their insulin syringes include variants like the droplet series and DropSafe models, which incorporate drop protection to prevent insulin loss during administration. For lancets, they provide safety designs (e.g., Acti-Lance and Medlance Plus) that reduce needle-stick injuries by retracting or guarding the needle after use. These innovations align with their focus on minimizing user risk and improving patient convenience.